Ultrasensitive Detection of Urine LAM for Point-of-Care Diagnosis of All Forms of Tuberculosis

ABSTRACT: Tuberculosis (TB) remains one of the most challenging diseases with ten million new cases and two million deaths yearly, and severe problems due to underdiagnosis and inadequate testing. A point-of-care (PoC) test for all kinds of TB that is sensitive, quick, simple, and not sputum-based is urgently needed. The most promising avenue to accomplish this is an immunoassay based on the TB biomarker Lipoarabinomannan (LAM). Fluxus Inc.’s long-term goal is to develop a novel suite of ultrasensitive, target-agnostic, low-complexity diagnostic instruments based on optofluidic single-molecule technology that combines integrated optics and microfluidics on a single chip-based system. The objective of this project is to develop the first PoC compatible system for detection of LAM in urine for TB diagnosis in collaboration with FIND (Foundation for Innovative New Diagnostics), the world’s leading non-profit organization for diagnostics for poverty-related diseases. The test will use single protein detection to achieve the sensitivity of PCR with the relative simplicity and speed of an immunoassay. Phase I will introduce the innovative elements at the core of the project and result in the demonstration of the critical performance parameters for a PoC test.